Trial Outcomes & Findings for Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes (NCT NCT03191396)

NCT ID: NCT03191396

Last Updated: 2019-10-15

Results Overview

Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 577 participants
• Primary outcome timeframe: Week 0, week 30
• Results posted on: 2019-10-15

Participant Flow

The trial was conducted at 77 sites in 11 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects): Bulgaria (9/ 9); Czech Republic (5/ 5); Finland (8/ 8); France (8/ 8); Hungary (8/ 8); Italy (4/ 4); Poland (3/ 3); Slovenia (4/ 4); Spain (5/ 5); Sweden (6/ 6); United Kingdom (17/ 17)

After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.

Participant milestones

Measure	Semaglutide 1.0 mg Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Study STARTED	290	287
Overall Study COMPLETED	287	282
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Semaglutide 1.0 mg Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Study Lost to Follow-up	0	3
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Total n=577 Participants Total of all reporting groups
Age, Continuous	60.1 Years STANDARD_DEVIATION 10.5 • n=93 Participants	58.9 Years STANDARD_DEVIATION 10.0 • n=4 Participants	59.5 Years STANDARD_DEVIATION 10.2 • n=27 Participants
Sex: Female, Male Female	130 Participants n=93 Participants	120 Participants n=4 Participants	250 Participants n=27 Participants
Sex: Female, Male Male	160 Participants n=93 Participants	167 Participants n=4 Participants	327 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	268 Participants n=93 Participants	269 Participants n=4 Participants	537 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	264 Participants n=93 Participants	268 Participants n=4 Participants	532 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants.

Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in HbA1c	-1.7 Percentage of glycosylated haemoglobin Standard Deviation 0.9	-1.1 Percentage of glycosylated haemoglobin Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants.

Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Body Weight (kg)	-5.8 kg Standard Deviation 4.7	-2.0 kg Standard Deviation 4.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Fasting Plasma Glucose (FPG)	-2.65 mmol/L Standard Deviation 2.19	-1.46 mmol/L Standard Deviation 2.42

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Mean change from baseline in 7-point profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile	-3.0 mmol/L Standard Deviation 2.0	-2.1 mmol/L Standard Deviation 2.3

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)	-1.0 mmol/L Standard Deviation 1.8	-0.4 mmol/L Standard Deviation 1.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Fasting Blood Lipids: Total Cholesterol	0.96 ratio Geometric Coefficient of Variation 16.8	0.98 ratio Geometric Coefficient of Variation 16.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol	0.99 ratio Geometric Coefficient of Variation 28.3	0.99 ratio Geometric Coefficient of Variation 27.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol	1.01 ratio Geometric Coefficient of Variation 14.6	0.99 ratio Geometric Coefficient of Variation 12.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Fasting Blood Lipids: Triglycerides	0.83 Ratio Geometric Coefficient of Variation 41.5	0.91 Ratio Geometric Coefficient of Variation 39.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants.

Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Body Mass Index (BMI)	-2.0 kg/sqm Standard Deviation 1.6	-0.7 kg/sqm Standard Deviation 1.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Waist Circumference	-5.2 cm Standard Deviation 5.6	-2.4 cm Standard Deviation 4.6

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants.

Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Systolic Blood Pressure	-4.3 mmHg Standard Deviation 13.4	-3.7 mmHg Standard Deviation 13.8

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants.

Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Diastolic Blood Pressure	-1.5 mmHg Standard Deviation 8.6	-1.3 mmHg Standard Deviation 8.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants.

Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Body Weight (%)	-6.1 percentage of body weight Standard Deviation 4.9	-2.0 percentage of body weight Standard Deviation 4.2

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target	80.4 percentage of participants	45.9 percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target	58.5 percentage of participants	24.8 percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve Weight Loss Above or Equal to 3%	72.7 percentage of participants	33.9 percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve Weight Loss Above or Equal to 5%	55.9 Percentage of participants	17.7 Percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve Weight Loss Above or Equal to 10%	19.1 Percentage of participants	4.4 Percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain	75.6 Percentage of participants	36.8 Percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Reduction Above or Equal to 1%	82.8 Percentage of participants	48.3 Percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%	62.4 Percentage of participants	20.9 Percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%	49.6 Percentage of participants	11.9 Percentage of participants

SECONDARY outcome

Timeframe: After 30 weeks of treatment

Population: Full analysis set (FAS), which included all randomised participants.

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%	17.1 Percentage of participants	3.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Physical functioning	1.8 scores on a scale Standard Deviation 5.8	1.4 scores on a scale Standard Deviation 6.6
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Role-physical	1.4 scores on a scale Standard Deviation 7.2	0.6 scores on a scale Standard Deviation 6.7
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Bodily pain	2.2 scores on a scale Standard Deviation 9.1	1.5 scores on a scale Standard Deviation 9.8
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains General health	2.7 scores on a scale Standard Deviation 7.9	1.6 scores on a scale Standard Deviation 7.7
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Social functioning	1.7 scores on a scale Standard Deviation 8.7	0.9 scores on a scale Standard Deviation 7.7
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Role-emotional	1.2 scores on a scale Standard Deviation 8.5	1.0 scores on a scale Standard Deviation 8.0
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Vitality	3.0 scores on a scale Standard Deviation 8.0	1.1 scores on a scale Standard Deviation 8.0
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Mental health	1.7 scores on a scale Standard Deviation 8.2	0.3 scores on a scale Standard Deviation 7.2
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Mental component summary	1.7 scores on a scale Standard Deviation 7.9	0.5 scores on a scale Standard Deviation 7.5
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Physical component summary	2.1 scores on a scale Standard Deviation 6.4	1.4 scores on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set (FAS), which included all randomised participants. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = "satisfaction with current treatment"; Q 2 = "hyperglycemia"; Q 3 = "hypoglycemia"; Q 4 = "flexibility"; Q 5 = "convenience"; Q 6 = "understanding of diabetes"; Q 7 = "recommend treatment to others"; and Q 8 = "willingness to continue". Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores.

Outcome measures

Measure	Semaglutide 1.0 mg n=290 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q6. Understanding of diabetes	0.6 scores on a scale Standard Deviation 1.4	0.5 scores on a scale Standard Deviation 1.3
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q7. Recommend treatment to others	0.7 scores on a scale Standard Deviation 1.5	0.7 scores on a scale Standard Deviation 1.4
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q8. Willingness to continue	1.0 scores on a scale Standard Deviation 1.8	0.9 scores on a scale Standard Deviation 1.8
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Treatment satisfaction summary score	4.6 scores on a scale Standard Deviation 7.0	4.2 scores on a scale Standard Deviation 6.6
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q1. Satisfaction with current treatment	0.9 scores on a scale Standard Deviation 1.7	0.9 scores on a scale Standard Deviation 1.5
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q2. Hyperglycemia	-2.1 scores on a scale Standard Deviation 2.1	-1.6 scores on a scale Standard Deviation 2.3
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q3. Hypoglycemia	0.1 scores on a scale Standard Deviation 1.7	0.1 scores on a scale Standard Deviation 1.6
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q4. Flexibility	0.7 scores on a scale Standard Deviation 1.5	0.6 scores on a scale Standard Deviation 1.5
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately Q5. Convenience	0.7 scores on a scale Standard Deviation 1.5	0.6 scores on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Week 0 to week 35

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Number of Treatment-emergent Adverse Events (TEAE)	758 Events	691 Events

SECONDARY outcome

Timeframe: Week 0 to week 35

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes	8 Episodes of hypoglycaemia	8 Episodes of hypoglycaemia

SECONDARY outcome

Timeframe: Week 0 to week 35

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Haematology - Haemoglobin	1.0 mmol/L Geometric Coefficient of Variation 16.0	1.0 mmol/L Geometric Coefficient of Variation 0.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Haematology - Haematocrit	1.5 percent change Geometric Coefficient of Variation 111.7	1.1 percent change Geometric Coefficient of Variation 130.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Haematology - Thrombocytes and Leukocytes Thrombocytes	18.4 10^9 cells/L Geometric Coefficient of Variation 126.0	21.5 10^9 cells/L Geometric Coefficient of Variation 138.9
Change in Haematology - Thrombocytes and Leukocytes Leukocytes	0.14 10^9 cells/L Geometric Coefficient of Variation 133.2	0.14 10^9 cells/L Geometric Coefficient of Variation 117.3

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Haematology - Erythrocytes	0.14 10^12 cells/L Geometric Coefficient of Variation 133.2	0.14 10^12 cells/L Geometric Coefficient of Variation 117.3

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Biochemistry - Calcium, Pottassium and Sodium Calcium	0.07 mmol/L Geometric Coefficient of Variation 107.0	0.07 mmol/L Geometric Coefficient of Variation 103.8
Change in Biochemistry - Calcium, Pottassium and Sodium Pottassium	0.3 mmol/L Geometric Coefficient of Variation 96.0	0.3 mmol/L Geometric Coefficient of Variation 77.3
Change in Biochemistry - Calcium, Pottassium and Sodium Sodium	1.8 mmol/L Geometric Coefficient of Variation 65.3	1.7 mmol/L Geometric Coefficient of Variation 61.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. Alkaline phosphatase	5.5 mmol/L Geometric Coefficient of Variation 117.5	6.4 mmol/L Geometric Coefficient of Variation 121.0
Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. Alanine Aminotransferase	5.3 mmol/L Geometric Coefficient of Variation 126.1	5.0 mmol/L Geometric Coefficient of Variation 137.7
Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. Aspartate Aminotransferase	3.5 mmol/L Geometric Coefficient of Variation 129.9	3.1 mmol/L Geometric Coefficient of Variation 119.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Biochemistry - Amylase and Lipase Amylase	10.3 U/L Geometric Coefficient of Variation 124.7	8.4 U/L Geometric Coefficient of Variation 138.2
Change in Biochemistry - Amylase and Lipase Lipase	15.8 U/L Geometric Coefficient of Variation 154.6	14.0 U/L Geometric Coefficient of Variation 154.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Biochemistry - Creatinine and Bilirubin Creatinine	4.1 umol/L Geometric Coefficient of Variation 150.2	3.6 umol/L Geometric Coefficient of Variation 150.0
Change in Biochemistry - Creatinine and Bilirubin Bilirubin	1.9 umol/L Geometric Coefficient of Variation 167.5	2.0 umol/L Geometric Coefficient of Variation 126.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Biochemistry - Albumin	0.2 g/dL Geometric Coefficient of Variation 56.8	0.2 g/dL Geometric Coefficient of Variation 55.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).	4.0 mL/min/1.73m2 Geometric Coefficient of Variation 97.7	4.1 mL/min/1.73m2 Geometric Coefficient of Variation 113.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Calcitonin	1.3 ng/L Geometric Coefficient of Variation 165.5	1.1 ng/L Geometric Coefficient of Variation 89.7

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.

Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Outcome measures

Measure	Semaglutide 1.0 mg n=289 Participants Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 Participants Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Change in Pulse Rate	2.4 beats/min Geometric Coefficient of Variation 10.1	3.9 beats/min Geometric Coefficient of Variation 10.0

Adverse Events

Semaglutide 1.0 mg

Serious events: 17 serious events

Other events: 139 other events

Deaths: 0 deaths

Liraglutide 1.2 mg

Serious events: 22 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide 1.0 mg n=289 participants at risk Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 participants at risk Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Gastrointestinal disorders Abdominal pain upper	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Renal and urinary disorders Acute kidney injury	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Cardiac disorders Bradycardia	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Renal and urinary disorders Calculus urinary	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Cardiac disorders Cardiac failure congestive	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Investigations Cardiovascular examination	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Hepatobiliary disorders Cholecystitis	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Hepatobiliary disorders Cholelithiasis	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Cognitive disorder	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Colitis	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Psychiatric disorders Confusional state	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Cardiac disorders Coronary artery disease	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Metabolism and nutrition disorders Dehydration	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Psychiatric disorders Depression	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Device related infection	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Diarrhoea	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
General disorders Facial pain	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Renal and urinary disorders Haematuria	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Inguinal hernia	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Lethargy	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Localised infection	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Reproductive system and breast disorders Menopausal symptoms	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Nausea	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Renal and urinary disorders Nephrolithiasis	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Pneumonia	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Reproductive system and breast disorders Prostatitis	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Pyelonephritis	0.69% 2/289 • Number of events 2 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Rectal abscess	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Eye disorders Retinal vein occlusion	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/287 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Sepsis	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Umbilical hernia	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Urinary tract infection	0.00% 0/289 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Vomiting	0.35% 1/289 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.35% 1/287 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

Other adverse events

Measure	Semaglutide 1.0 mg n=289 participants at risk Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Liraglutide 1.2 mg n=287 participants at risk Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Gastrointestinal disorders Abdominal pain	5.2% 15/289 • Number of events 18 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	2.1% 6/287 • Number of events 6 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Constipation	5.9% 17/289 • Number of events 17 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	3.5% 10/287 • Number of events 13 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Metabolism and nutrition disorders Decreased appetite	10.4% 30/289 • Number of events 31 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	5.9% 17/287 • Number of events 18 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Diarrhoea	15.6% 45/289 • Number of events 56 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	12.2% 35/287 • Number of events 43 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Headache	9.3% 27/289 • Number of events 37 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	6.6% 19/287 • Number of events 32 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Influenza	3.1% 9/289 • Number of events 12 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	5.2% 15/287 • Number of events 16 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Nasopharyngitis	9.3% 27/289 • Number of events 30 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	10.5% 30/287 • Number of events 32 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Nausea	21.5% 62/289 • Number of events 88 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	15.7% 45/287 • Number of events 54 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Vomiting	10.0% 29/289 • Number of events 43 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	8.0% 23/287 • Number of events 32 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

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Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
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